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NCT05377112 · ClinicalTrials.gov registry record · Early Phase 1
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
A Early Phase 1 study, sponsored by Synlogic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT05377112: Completed Early Phase 1 study, sponsored by Synlogic.
NCT05377112 is a Early Phase 1 study that has completed, run by Synlogic. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05377112, a Early Phase 1 study, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.
Primary Outcome
Vital Signs Resting vital signs will be collected as specified in the protocol. Subjects are required to remain in the sitting position for at least 5 minutes prior to obtaining vital signs. A symptom-directed physical examination will be performed by trained medical personnel as specified in the protocol.
Interventions
- OTHER Placebo
- DRUG SYNB8802v1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2022-12-07 |
| Phase | Early Phase 1 |
What the finished NCT05377112 record still lists
NCT05377112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05377112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05377112 about?
NCT05377112 is a clinical study titled "Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome". Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.
What is the current status of trial NCT05377112?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2022-03-29. Estimated completion is 2022-12-07.
What interventions are being tested in trial NCT05377112?
The interventions under investigation include: Placebo (OTHER), SYNB8802v1 (DRUG).
Who is sponsoring clinical trial NCT05377112?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05377112's enrollment target sits among peer trials
11 1601st of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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